Anti-rotation cartridge pin

ABSTRACT

A system is disclosed for inserting a pharmaceutical cartridge into a delivery device. Optionally the cartridge is inserted in an arbitrary orientation. Optionally, the system reorients the cartridge to a locked orientation. For example, a driver applies a torque to the cartridge to cause the reorienting. For example, said torque rotates the cartridge around an axis thereof until the cartridge reaches the locked orientation. Optionally, when the cartridge reaches the locked orientation an interference element on the cartridge interlocks with a complementary interference element on the delivery device to lock the cartridge in the locked orientation. Optionally when the cartridge is locked in the second orientation, the torque causes discharge the pharmaceutical.

RELATED APPLICATION

This application claims the benefit of priority under 35 USC 119(e) of

U.S. Provisional Patent Application No. 62/369,492 filed Aug. 1, 2016,the contents of which are incorporated herein by reference in theirentirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates a method andsystem for loading a cartridge into a pharmaceutical device andparticularly, but not exclusively, to a system and method forfacilitating proper stabilization of the cartridge.

U.S. Pat. No. 8,157,769 relates to “A cartridge insertion assemblyincluding apparatus with a pathway formed therein, a cartridgeinsertable into the pathway, the cartridge including a cartridgecoupling element connectable to an activation mechanism disposed in theapparatus operative to cause a substance contained in the cartridge tobe metered out of the cartridge, and a door pivoted to the apparatusthat includes a door coupling element arranged with respect to thecartridge such that when the door is in a fully closed position, thedoor coupling element couples the cartridge coupling element with acoupling element of the activation mechanism”.

U.S. Pat. No. 7,967,795 relates to “A cartridge interface assemblyincluding a driving plunger including an outer shaft, and a driverincluding an inner shaft, the inner shaft mating with an intermediateshaft, the intermediate shaft mating with the outer shaft, so that theshafts are movable telescopically with respect to one another, whereinrotation of the driver causes the driving plunger to advance in adirection away from the driver”.

U.S. Pat. No. 9,173,997 relates to an apparatus “For administering asubstance to a subject. A vial contains the substance and a stopper isdisposed within the vial and is slidably coupled to the vial. A firstthreaded element is (a) rotatable with respect to the vial and (b)substantially immobile proximally with respect to the vial duringrotation of the first threaded element. A second threaded element isthreadably coupled to the first threaded element. At least a distal endof the second threaded element is substantially non-rotatable withrespect to the vial, and the distal end of the second threaded elementdefines a coupling portion that couples the second threaded element tothe stopper. The first threaded element, by rotating, linearly advancesthe stopper and at least the distal end of the second threaded elementtoward a distal end of the vial. Other embodiments are also described.”

SUMMARY OF THE INVENTION

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

According to an aspect of some embodiments of the invention, there isprovided a system for loading pharmaceutical into a pharmaceuticaldelivery device including: a cartridge including a cylindrical reservoirhaving a longitudinal axis and containing the pharmaceutical; acartridge bay in the pharmaceutical delivery device, the bay sized andshaped to receive the cartridge with the cylindrical reservoir rotatedin any of a first orientation and a second orientation rotated aroundthe longitudinal axis; a first interference element on the cartridge anda second complementary interference element on the delivery device,wherein the first interference element on the cartridge and a secondcomplementary interference element are disengaged when the cartridge isfully received by the bay and the reservoir is in any of the firstorientation and the second orientation; the first interference elementand second complementary interface element interlocking when thecartridge is fully loaded into the bay and the cartridge is in a thirdorientation around the longitudinal axis, the interlocking preventingrotation of the reservoir around the longitudinal axis in at least onedirection.

According to some embodiments of the invention, in the cartridge fitsinto the bay by longitudinal insertion.

According to some embodiments of the invention, the first interferenceelement is located on a leading face of the cartridge.

According to some embodiments of the invention, the complementaryinterference element contacts the cartridge only when the cartridge ismore than 97% inserted into the bay.

According to some embodiments of the invention, the complementaryinterference element is longitudinally displaced by the cartridge afterthe cartridge is inserted into the bay at least 97% of its fullinsertion.

According to some embodiments of the invention, in the first orientationthe first interference element and the second complementary interferenceelement overlap in and at least one element of the first interferenceelement and the second complementary interference element is configuredfor elastically displacing to accommodate the overlap.

According to some embodiments of the invention, when the at least oneelement is configured to apply a resistance to insertion of thecartridge into the cartridge bay as a result of the elasticallydisplacing.

According to some embodiments of the invention, the system furtherincludes a lock configured for counteracting the resistance.

According to some embodiments of the invention, the lock includes alatch.

According to some embodiments of the invention, in the first orientationthe first interference element and the second complementary interferenceelement are disengaged facilitating rotation either direction around thelongitudinal axis with respect to the delivery device around.

According to some embodiments of the invention, in the third orientationthe interlocking of the first interference element and the secondcomplementary interference element inhibits rotation of the cartridgearound the longitudinal axis with respect to the delivery device in twoopposite directions.

According to some embodiments of the invention, the system furtherincludes a driver for imparting a torque between the pharmaceuticaldelivery device and the cartridge around the longitudinal axis.

According to some embodiments of the invention, the driver is configuredto drive discharge of the pharmaceutical when the cartridge is preventedfrom rotating around axis in the at least one direction.

According to some embodiments of the invention, the driver includes athreaded element.

According to some embodiments of the invention, the drive pushes aplunger axially inside of the cylindrical reservoir.

According to some embodiments of the invention, the driver includes atelescoping screw assembly.

According to some embodiments of the invention, the driver applies thetorque to the threaded element and the threaded element is threadablyconnected to a second threaded element and the second threaded elementis inhibited from rotating around the longitudinal axis with respect tothe cartridge.

According to an aspect of some embodiments of the invention, there isprovided a method of loading a pharmaceutical cartridge having acylindrical reservoir into a delivery device including; inserting thecartridge longitudinally into a cartridge bay of the delivery device ina first orientation; applying a torque to the cartridge with a driver;reorienting the cartridge to a second orientation around a longitudinalaxis of the reservoir as a result of the applying a torque; interlockingan interference element on the cartridge to a complementary interferenceelement on the delivery device to lock the cartridge in the secondorientation; discharging a pharmaceutical from the cartridge as a resultof continuing the applying and the interlocking.

According to some embodiments of the invention, the method furtherincludes: elastically displacing an interference element as a result ofthe inserting; at least partially releasing the elastically displacingwhen the cartridge reaches the second orientation.

According to some embodiments of the invention, the elasticallydisplacing produces a resistance to the inserting and further including:fixing the cartridge in the cartridge bay after the elasticallydisplacing and wherein the fixing at least partially counteracts theresistance.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a flow chart of illustration of inserting and/or orientatingand/or locking a cartridge in accordance with an embodiment of thecurrent invention;

FIGS. 2A and 2B are a block diagram of illustrations of cartridgestabilization systems in accordance with embodiments of the currentinvention;

FIGS. 3A-3D are schematic illustrations of a cartridge stabilizationsystem in accordance with an embodiment of the current invention;

FIGS. 4A and 4B are schematic illustrations of an alternative cartridgestabilization system in accordance with an embodiment of the currentinvention;

FIG. 5 is a flow chart of illustration of inserting and/or orientatingand/or locking a cartridge in accordance with an embodiment of thecurrent invention;

FIG. 6 is a perspective cut-away illustrations of a pharmaceuticaldelivery device including a cartridge stabilization system in accordancewith an embodiment of the current invention;

FIG. 7 is a schematic proximal cut-away illustration of a pharmaceuticaldelivery device including a cartridge stabilization system in accordancewith an embodiment of the current invention;

FIGS. 8A and 8B are perspective cut-away illustrations of apharmaceutical delivery device including a cartridge stabilizationsystem in accordance with an embodiment of the current invention;

FIGS. 9A-9C are photographs of a cartridge stabilization system inaccordance with an embodiment of the current invention.

FIG. 10 is a schematic illustration of a pharmaceutical cartridge inaccordance with an embodiment of the current invention;

FIG. 11 is a schematic illustration of a pharmaceutical cartridge inaccordance with an embodiment of the current invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates a method andsystem for loading a cartridge into a pharmaceutical device andparticularly, but not exclusively, to a system and method forfacilitating proper stabilization of the cartridge.

Overview

An aspect of some embodiments of the current invention relates to systemfor stabilizing a pharmaceutical cartridge into a fixed orientation. Thecartridge stabilization system optionally allows introduction of acartridge into a cartridge bay in either the locked orientation and/oranother orientation and/or reorients the cartridge to the lockedorientation and/or stabilization the cartridge in the lockedorientation.

In some embodiments, a stabilization system will be configured to avoidinterference with insertion of a cartridge. For example, thestabilization system may allow insertion of the cartridge in a lockedorientation and/or in another orientation and/or in an arbitraryorientation.

In some embodiments, the mechanism by which the cartridge is locked willnot apply against the insertion of the cartridge. For example, for alongitudinally inserted cartridge, an interference force may resistrotation around the longitudinal axis, but not longitudinal movement.Alternatively, or additionally the force of the locking mechanism mayresist insertion only in a portion of the insertion trajectory. Forexample, resistance to insertion may be at the beginning or end of theinsertion process. Optionally, the force resisting insertion may be lessthan 1/100 the force resisting the locking direction and/or theinsertion resistance may range between 1/100 to 1/50 of the force oflocking, and/or the insertion resistance may range between 1/50 to 1/10of the force of locking, and/or the insertion resistance may rangebetween 1/10 to ½ of the force of locking. For example, a resistance toinsertion may be applied to less than ½ of the insertion trajectoryand/or over less than ¼ of the insertion trajectory and/or less than ⅛of the insertion trajectory and/or less than 1/20 of the insertiontrajectory.

In some embodiments, a cartridge stabilization system may assistcartridge insertion. For example, a cartridge stabilization system mayadd a resistance force that stops when a cartridge is fully insertedinto a pharmaceutical delivery device. For example, the stabilizationsystem may serve as a tactile indication to a user indicating that thecartridge is fully installed. For example, the interference element mayexert a force ranging between 200 to 400 g and/or between 400 to 800 gand/or between 800 to 2000 g when it is deflected. For example theinterference element may deflect between 0.5 to 1.0 mm and/or between1.0 to 1.5 mm and/or between 1.5 to 3 mm. For example the ratio betweenthe force and/or distance of deflection of the interference element whenit interlocks to a complementary interference element to the forceand/or distance of deflection when the interference element overlaps thecomplementary interference element may range between 0 to 0.3 and/orbetween 0.3 to 0.6 and/or between 0.6 to 0.9 and/or between 0.9 to 1.0.Optionally, the interlocked interference elements may hold a cartridgeimmobile and/or stable for a torque ranging between 0 to 200 g-cm and/orbetween 0 to 500 g-cm and/or between 0 to 1000 g-cm. In some embodimentsthe axial force developed by a driver on a plunger, for example duringpharmaceutical delivery ranges between 0.5 to 2 kg and/or between 2 to 4kg and/or between 4 to 10 kg.

In some embodiments, the cartridge is reoriented to a final and/orlocked position after insertion. Optionally, a driver, which drivesdelivery of a pharmaceutical, will also drive reorientation of acartridge. For example, a drive may apply a torque to a cartridge. Thetorque my reorient the cartridge until the stabilization systemstabilizes the cartridge in the locked orientation. Optionally, when thecartridge is locked, the driver may begin continue to drive thecartridge.

Optionally, after locking the force of the driver may perform adifferent function from reorienting. For example, once the cartridge islocked and/or resists rotation, the torque of the driver may beconverted into a force discharging and/or delivering the pharmaceuticaland/or drive a preparation for discharge, for example pushing a plungerdriver and/or a plunger and/or piercing a septum.

In some embodiments, a locking mechanism includes an interferenceelement.

Optionally, the interference element does not interfere with movementwhen the cartridge is not in the locked position. Alternatively oradditionally, the interference element may be elastically pushed out ofa locking position when the cartridge is not in a locked position.Alternatively or additionally, an interference element will produce aforce in one direction (for example, a resistance to insertion due tofriction and/or elastic forcing of the interference element) while thecartridge is out of the locked position and/or the interference elementwill produce a different force (for example blocking rotation) in thelocked position. In some embodiments, the non-locking positions mayinclude for example angles covering between 359 to 300 degrees oforientations and/or between 300 to 200 degrees and/or between 200 to 100degrees and/or between 100 to 50 degrees and/or between 50 to 2 degrees.

In some embodiments, a cartridge will include an interference element ona leading face and/or surface thereof (a leading face and/or surface mayinclude a surface that is facing the direction of travel as thecartridge is inserted into the delivery device). For example, for acartridge that is optionally pushed distally into a cartridge bay theinterference element may optionally be located on a distal face of thecartridge. Optionally, the interference element does not interlock witha complementary element and/or does not interfere with insertion of thecartridge until the distal face is inserted to reach a complementaryinterference element of the delivery device. For example, theinterference elements may interact in an area ranging between the last ½to the last 1/10 of the insertion and/or between the last 1/10 to thelast 1/100 of the insertion. For example, the interference elements mayinteract in an area ranging between the last 2 cm to the last 4 mm ofthe insertion and/or between the last 4 mm to the last 0.4 mm of theinsertion.

In some embodiments, a driver includes an antirotational connection to apharmaceutical reservoir. For example, a plunger and/or a friction padmay supply anti-rotational friction between an inner wall of a reservoirand the driver.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Flow Chart of an Exemplary Method of Stabilizing a Cartridge

FIG. 1 is a flow chart illustration of inserting and/or orientatingand/or locking a cartridge in accordance with an embodiment of thecurrent invention. In some embodiments, a user inserts 102 apharmaceutical cartridge into a delivery device in an arbitraryorientation. Optionally, the device reorients 104 the cartridge until itreaches a locked orientation 106 and locks 108. For example, the driverthat drives discharge 110 of the pharmaceutical also drives orientationof the cartridge.

In some embodiments, a user inserts 102 a pharmaceutical cartridge intoa delivery device. For example, a pharmaceutical cartridge may include atubular reservoir that is inserted longitudinally into a cartridge bay.For example, a cartridge may include a syringe and/or a vial and/or anampoule. In some embodiments, during delivery the cartridge may bestabilized in the cartridge bay at a fixed orientation. Nevertheless, itmay be desirable that the device perform properly when the user inserts102 the cartridge in an arbitrary orientation. Furthermore, it may bedesirable that the locking mechanism not impede cartridge insertion. Forexample, a friction based stabilization may impede insertion of thecartridge. Optionally, the cartridge is inserted 102 while the lockingmechanism is disengaged.

In some embodiments, a user initiates the device. For example,initiating the device may include activating 103 a driver ofpharmaceutical delivery. Optionally, initially, for example while thecartridge in unlocked, the driver may not drive delivery of thepharmaceutical. For example, initially, the driver may drivereorientation 104 of the cartridge. Optionally, the cartridge willcontinue to reorient 104 until it reaches a locked orientation 106and/or is locked 108.

In some embodiments, a delivery driver will continue to operate 109after a cartridge is locked 108 and/or in its locked orientation 106.Optionally, continued operation 109 of the driver discharges 110 thepharmaceutical and/or delivers the pharmaceutical to a subject.

Embodiments of a Cartridge Stabilize

FIG. 2A is a block diagram of illustration of cartridge stabilizationsystem in accordance with an embodiment of the current invention. Insome embodiments, a delivery device 201 includes a cartridge bay 204that accommodates a pharmaceutical reservoir 202. For example, bay 204may accommodate reservoir 202 in more than one possible orientation.Optionally, when reservoir 202 is in a locked orientation, complementaryinterference elements 218 and 208 on the cartridge and bay respectivelyinterlock and/or lock the cartridge into the locked orientation.Optionally, when the cartridge is in a non-locked orientation,interference elements 218 and 208 overlap. Optionally, when thecartridge is in a non-locked orientation at least one of interferenceelements 218 and 208 is elastically displaced.

In some embodiments, delivery device 201 includes a driver 203.Optionally driver 203 drives reorientation of reservoir 202 in bay 204.For example, driver 203 may produce a torque that rotates reservoir 202.Optionally, the torque may reorient cartridge, for example by rotatingreservoir 202 around an axis inside bay 204. Optionally, when reservoir202 reaches a particular orientation (for example a locked orientation),interference element 218 on the cartridge interlocks with interferenceelement 208 on the delivery device and/or stops reorientation of thecartridge with respect to the device.

In some embodiments, when reservoir 202 is locked, further torque ofdriver 203 drives delivery of the pharmaceutical. For example, reservoir202 may include a pharmaceutical reservoir and/or a pump for discharginga pharmaceutical from the reservoir. For example, driver 203 may impel aplunger into the reservoir to discharge the pharmaceutical fromreservoir 202.

In some embodiments, driver 203 may include a telescoping screw assembly(TSA) and/or a plunger interface. For example, driver 203 may include amotor (for example a DC electric motor and/or a brushless electric motorand/or a chemical powered motor). The motor optionally applies a torquebetween the TSA and a chassis 212 of the delivery device. Optionally theTSA applies the torque to the plunger; the plunger optionally appliesthe torque to the reservoir. For example, as long as reservoir 202 isfree to rotate, the torque of the motor rotates reservoir 202. Whenreservoir 202 is locked by interlocked interference elements 208 and/or218, to the cartridge produces a counter torque, which is transmitted tothe TSA. Optionally the torque and counter torque on the TSA may causescrew threads in the TSA to rotate with respect to each other expandingthe telescoping assembly and/or driving the plunger and/or dischargingthe pharmaceutical. Alternatively or additionally, a driver may includea linear actuator and/or a piston assembly, which drives discharge.Alternatively or additionally, torque may be transferred between thecartridge and the driver by friction between the plunger and the innerwall of the reservoir and/or by a friction element (for example afriction pad contacting and inner wall of the reservoir) and/or by aninterference element.

FIG. 2B is a block diagram illustrating and alternative pharmaceuticaldelivery device in accordance with an embodiment of the currentinvention. In some embodiments, a drug delivery device 201 may include amotor 230. Optionally, motor 230 drives a transmission 205. For example,transmission 205 may transmit rotational energy to a telescoping screwassembly, TSA 233. Optionally TSA 233 is connected to a plunger 286 of areservoir 202. For example, torque from motor 230 may rotate an entirecartridge (for example including transmission 205, TSA 233, plunger 286and/or reservoir 202). Alternatively or additionally, when reservoir 202and/or plunger 286 are prevented from rotating, rotating transmission205 may rotate on part of TSA 233 with respect to a threadably connectedsecond part of TSA 233. Rotation of the threadably connected parts withrespect to one another optionally expands TSA 233 and/or pushes plunger286 into the reservoir, for example driving discharge of apharmaceutical.

Exemplary Surfaces of Contact with a Cartridge

FIGS. 3A-3D are schematic illustrations of a cartridge stabilizationsystem in accordance with an embodiment of the current invention.Optionally, a cartridge may include a cylindrical reservoir 302, whichis inserted longitudinally into a delivery device in an arbitraryorientation. Cylindrical reservoir 302 optionally is free to rotateuntil an interference element 308 of the delivery device interlocks witha complementary feature on the cartridge inhibiting further rotation ofthe cartridge with respect to the delivery device.

In some embodiments, reservoir 302 includes a groove 317 and/or acomplementary interference element, for example a protruding section 318configured to interlock with an interference element 308 on the deliverydevice. Optionally, interference element 308 is elastic. For examplewhen groove 317 is not aligned with interference element 308 and/or whenprotruding section 318 overlaps interference element 308 (for example asillustrated in FIGS. 3A and 3B) then element 308 may flex out of the wayof cartridge 302 allowing insertion of cartridge 302 into the deliverydevice and/or allowing rotation of cartridge 302 with respect to thedelivery device.

In some embodiments, when groove 317 is aligned with element 308, thenelement 308 and protruding section 318 interlock. For example, element308 may be biased toward groove 317 such that when they are alignedelement 308 snaps into groove 317 and/or interlocks (for example asillustrated in FIGS. 3C and/or 3D). Optionally, interlocking may allowlongitudinal movement of the cartridge with respect to the device.Optionally, interlocking may inhibit further rotation of cartridge withrespect to the device.

FIGS. 4A and 4B are schematic illustrations of an alternative cartridgestabilization system in accordance with an embodiment of the currentinvention. In some embodiments, a cartridge includes a complementaryinterference element on a leading face of the cartridge. For example,the cartridge may be inserted distally into a cartridge bay. Thecomplementary interference element of the cartridge may be on a distalface of the cartridge. For example, the distal face may encounter aninterference element of the delivery device when as the cartridgeapproaches complete insertion into the delivery device. Optionally, theinterference elements will not inhibit (and/or affect) the beginning ofcartridge insertion.

In some embodiments, a cartridge may include a reservoir 402 having aproximal flange 416. Optionally, an interference element 408 on thedelivery device interacts with a complementary element on the cartridge.For example, the distal face 419 of flange 416 may include a grooveand/or a protrusion that interlocks with element 408 when cartridge isin a particular orientation. For example, when element 408 overlaps withthe protrusions either element 408 or the protrusion may be elasticallydisplaced. For example, when element 408 is aligned with the groove itmay snap into the groove and/or interlock with the protrusion and/orlock the orientation of reservoir 402. Optionally, element 408 willcontact flange 416 during the last 1 mm of cartridge insertion. Forexample, at the end of insertion, elastic forces of element 408 may pushthe cartridge outward from the cartridge bay until the cartridge reachesa fully in inserted position. At the fully inserted position, thecartridge may be fixed in place, fixing the cartridge may include anopposing force to the outward force of element 408. For example, theresistance force of element 408 and/or the nullification of theresistance may serve as a tactile sign to the user that the cartridgehas been fully inserted.

In some embodiments, a cartridge includes a TSA 403. For example, TSA403 may be connected to a transmission, for example including a drivegear 405.

Optionally, when the cartridge is inserted into the delivery device, thetransmission connects to a motor that drives TSA to rotate the cartridgeand/or to discharge the pharmaceutical.

Exemplary Stabilizing of a Cartridge and/or Discharging of aPharmaceutical

FIG. 5 is a flow chart of illustration of inserting and/or orientatingand/or locking a cartridge in accordance with an embodiment of thecurrent invention. In some embodiments, the locking mechanism does notaffect cartridge insertion until the cartridge is close to the end ofinsertion. At the end of insertion, the interference element of thedelivery device optionally contacts a complementary surface and/orelement of the cartridge. For example, the complementary surface may bea surface with a portion that interlocks to the interference elementand/or a portion that facilitate reorientation of the cartridge until aninterlocking portion of the surface contacts the interference element.

In some embodiment, a cartridge is freely inserted 502 into a deliverydevice.

Optionally, the cartridge may be inserted 502 in various and/orarbitrary orientations. For example, for a cartridge with a cylindricalreservoir, the cartridge optionally is inserted in any rotationalorientation around the longitudinal axis of the reservoir. Optionally, astabilization system does not interfere with insertion at least forinsertion to between 50 to 90% and/or between 90 to 97% and/or between97 to 99% of its fully inserted depth. For example, the stabilizationsystem may not interfere with the orientation of the cartridge and/orapply a force to the cartridge before it is inserted to the stateddepth. Alternatively or additionally, the stabilization system may applyan average force over the beginning portion of insertion that is lessthan ½ and/or less than 1/10 and/or less than 1/100 the average forceover the final portion of insertion.

In some embodiments, the cartridge may contact 524 an interferenceelement of a stabilization system during a final portion of insertionafter an initial portion of insertion.

For example, the initial portion of insertion may range between 50%inserted to 90% inserted and/or between 90% to 95% and/or between 95% to99% and/or greater than 99% of the fully inserted depth. For example,after the cartridge contacts 524 the interference element, the elementmay produce resistance to further insertion and/or an outward force. Forexample, the outward force may push the cartridge out from the cartridgebay. Optionally, when the cartridge is fully inserted it may be fixed526 in the cartridge bay. For example, the fixing 526 may counteractand/or nullify the outward force of contact 526 with the interferenceelement.

Optionally, the resistance resulting from contact 524 with theinterference element may serve the user as a sign that the cartridge isapproaching full insertion and/or has not reached full insertions.Optionally, fixing 526 may serve the user as a sign that the cartridgeis properly and/or fully inserted.

In some embodiments, after a cartridge is fully inserted 502 and/orfixed 526, a user may place the pharmaceutical delivery device onto adelivery site and/or activate 503 the device. Optionally, when thedevice is active and the cartridge is in a non-locked orientation [no indecision box 506] (for example, an interference element in the cartridgebay in not aligned and/or not interlocking with a complementary featureon the cartridge and/or an interference elements on the delivery deviceoverlaps an interference element on the cartridge) then one of theinterference element may be displaced elastically 520. For example,elastic displacement 520 may be by elastic deformation of theinterference element and/or the interference element may have an elasticmount (for example a spring and/or an elastic joint) that deformselastically. For example, the displacement may be caused by overlap ofthe interference element with a complementary interference element.Optionally, when the cartridge is in a non-locked orientation [no indecision box 506], action of a driver on the cartridge may reorient 504(for example rotate) the cartridge. Optionally, the driver continues toreorient 504 the cartridge with respect to the delivery device until thecartridge reaches the locked orientation.

In some embodiments, when the cartridge is in a locked orientation [yesin decision box 506], an interference elements on the cartridge and/ordelivery device may interlock 522. Interlocking 522 may orientationallylock 508 the cartridge in the locked orientation. Optionally, when thecartridge is orientationally locked 508, the driver may continue tooperate 109. For example, continued operation 109 of the driver when thecartridge in orientationally locked 508 may cause delivery and/ordischarge 110 of the pharmaceutical.

Detailed Embodiments of a Cartridge Stabilizing System

FIG. 6 is a perspective cut-away illustration of a pharmaceuticaldelivery device including a cartridge stabilization system in accordancewith an embodiment of the current invention. In some embodiments, areservoir fits into a cartridge bay. As reservoir is inserted, a leadingface optionally contacts an interference element of the delivery device.Optionally, in some orientations, a protrusion on the leading facecontacts the interference element and/or elastically displaces theinterference element.

Optionally, in some orientations, a depression on the leading facecontacts the interference element. For example, a depression and/or aprotrusion may include a complementary interference element thatoptionally interlocks with the interference element of the deliverydevice and/or locks the orientation of reservoir.

In some embodiments, when a reservoir is almost fully inserted, aninterference element 608 of the delivery device contacts a leading face619 including complementary element 618. For example, face 619 mayinclude protrusions and/or depressions 617 (for example, a complementaryinterference element 618 may include a protrusion in face 619). Wheninterference element 608 contacts face 619, element 608 is elasticallydisplaced. For example, when element 608 contacts face 619, element 608bends distally. Optionally, displacing element 608 causes resistance tocartridge insertion. In some embodiments, inserting the reservoirfurther after contacting element 608, further displaces element 608and/or activates a longitudinal fixing mechanism that fixes thecartridge in the cartridge bay.

In some embodiments, a reservoir 602 of the cartridge includes aconnector. For example, reservoir 602 includes a septum 638. Optionally,the delivery device 650 includes a complimentary connector, for example,a hollow needle 636.

Optionally, as the cartridge reaches its locked position needle 636punctures septum 638 and creates a fluid path between reservoir 602 andthe delivery device 650.

In some embodiments, the pharmaceutical delivery device 650 includes aclosure element. For example, the pharmaceutical delivery device 650 mayinclude a door 640 to the cartridge bay 604. For example, the door 640rotates around an axle 640 to open and/or close.

In some embodiments, a closure element, for example door 640 mayincludes parts of a driver of the delivery device. For example, door 640includes a second axle 642, which optionally supports a connectionbetween the cartridge and the delivery device 650. For example, theconnection may include a gear that connects a TSA of the cartridge to amotor of the delivery device 650. An exemplary, the drive system ofdevice 650 and/or reservoir 602 is shown, for example in more detail inFIG. 7.

In some embodiments, a cartridge includes a flange 616. For example, alatch in device 650 may block flange 616 when reservoir 602 is fullyinserted into bay 604 and/or longitudinally fix reservoir 602 into bay604.

FIG. 7 is a schematic proximal cross sectional illustration ofpharmaceutical delivery device 650 including a cartridge stabilizationsystem in accordance with an embodiment of the current invention. Insome embodiments, delivery device 650 includes a motor 730. For example,motor 730 is connected by a transmission 616 to a TSA 703. Optionally,when motor 730 is connected to TSA 703, motor 730 rotates TSA 703.

In some embodiments, a motor 730 is mounted to chassis 612 of thedelivery device 650. Optionally, motor 730 rotates a gear 786 withrespect to chassis 612. Another gear 784 is optionally mounted on axle641 of door 640. For example when door 640 is closed (for example asillustrated in FIG. 7), gear 784 interconnects between gear 786 andtransmission 705. Optionally, when gear 786 is connected to transmission705, rotating gear 786 causes TSA 703 to rotate with respect to chassis612.

In some embodiments, TSA 703 is rotationally interlocked to reservoir602.

Optionally, when reservoir 602 can rotate with respect to chassis 612then rotating transmission 705 rotates reservoir 602. Alternatively oradditionally, when reservoir 602 is rotationally locked with respect tochassis 612, then rotating transmission 705 rotates one end of TSA 703with respect to the other end of TSA 703. Rotating one end of TSA 703with respect to the other end of TSA 703 optionally causes TSA 703 toexpand or contract. For example, expanding TSA 703 may push a plungerinto the reservoir and/or discharge a pharmaceutical.

In some embodiments, a latch 788 fixes the cartridge into bay 604. Forexample, when the cartridge is inserted into bay 604, latch 788 flexesdownward to allow flange 616 to enter bay 604. Alternatively oradditionally, when the cartridge it's fully inserted into bay 604, latch788 snaps upward, blocking flange 616 into position and/or fixing thecartridge inside bay 604. Optionally, latch 788 produces a counter forceat least partially negating the resistance to insertion of the elasticdisplacement of interference element 608.

FIGS. 8A and 8B are perspective cut-away illustrations of pharmaceuticaldelivery device 650 including a cartridge stabilization system inaccordance with an embodiment of the current invention. In someembodiments, when leading face 619 of a cartridge contacts interferenceelement 608, the face 619 and/or the interference element 608 may beelastically displaced. Optionally, elastic displacement may occur whenan interference element 618 on the cartridge is interlocks with acomplementary element 608 on the delivery device 650, for example wheninterference element 608 overlaps an indentation 617 on face 619.Alternatively or additionally, elastic displacement may occur when aninterference element 618 on the cartridge is not aligned with acomplementary element 608 on the delivery device, for example, wheninterference element overlaps with a projection. The elasticdisplacement force may give a tactile feedback to a user helping himknow when the cartridge has been completely inserted. In someorientations, the elements 608 and/or 618 may stabilize the orientationof the cartridge.

FIG. 8A illustrates an exemplary embodiment of the current inventionwith a reservoir 602 fully inserted into a bay 604. In FIG. 8A reservoir602 is optionally oriented such that interference elements 608 and 618are not aligned. For example, interference element 608 may overlapand/or be elastically displaced by a protrusion on face 619 of thecartridge. In some embodiments, when reservoir 602 is fully insertedinto bay 604 a latch 788 fixes flange 616 into the delivery device.

In some embodiments, a protrusion on leading face 619 of reservoir 602pushes interference element 608 and/or elastically displaces element608. Element 608, optionally, forces reservoir 602 backwards giving atactile resistance to the user.

Optionally, when interference element 608 is not aligned withinterference element 618, reservoir 602 is free to rotate around itsaxis.

In some embodiments, a driver, for example TSA 703 causes the reservoir602 to rotate. Optionally, reservoir 602 rotates until interferenceelement 608 is aligned with interference element 618. Alternatively oradditionally, reservoir 602 may be inserted into bay 604 in anorientation with interference elements 608 and 618 already aligned.

In some embodiments, for example, as Illustrated in FIG. 8B, wheninterference element 608 is aligned with element 618, then interferenceelement 608 snaps into a groove and/or indentation 617 of face 619and/or interlocks with a complementary interference element 618 and/orlocks the orientation of reservoir 602.

Optionally, interference element 608 is less displaced or not alldisplaced when it is aligned with element 618 than when it overlapselement 618. For example, when the interference elements are aligned theelastic displacement and/or elastic force may range between 50% to 90%the displacement when the elements are not aligned (for example whenthey overlap) and/or between 20% to 50% and/or between 1% to 20% and/orwhen aligned there may be no elastic displacement of the interferenceelements and/or not elastic force between the cartridge and the deliverydevice.

In some embodiments, when reservoir 602 is fully inserted into bay 604,a connection and/or a fluid path may be created between reservoir 602and delivery device 650. For example, a hollow needle 636 may puncture aseptum 638 of a reservoir 602. Optionally, puncturing septum 638 maycreate a fluid path between device 650 and reservoir 602. Illustrated,for example, in FIGS. 8A and 8B is a hinge 841 of device 650 aroundwhich hinge 641 and/or door 640 revolve

FIGS. 9A-9C are photographs of a cartridge stabilization system inaccordance with an embodiment of the current invention. In someembodiments, a cartridge 902 is inserted into a cartridge bay.Optionally, a leading face 919 of cartridge 902 approaches aninterference element 908. As the cartridge approaches full insertion,face 919 optionally contacts the interference element 908 either inalignment (with an interference element 917 of the cartridge aligned tointerference element 908) or not in alignment. For example, when theface 919 contacts the interference element 908 not in alignment (forexample as illustrated in FIG. 9B), the cartridge 902 is optionallyreoriented 955 until it aligns with the interference element 908. Forexample, when the cartridge 902 is in alignment, an interference element917 on the leading face 919 of the cartridge may in interlock with theinterference element 908 of the delivery device (for example asillustrated in FIG. 9C). Once the interface elements are interlocked,the orientation of the cartridge 902 is optionally locked with respectto the delivery device. In some embodiments, when the cartridge 902 islocked further action of the driver powers pharmaceutical delivery.

FIG. 9A shows leading face 919 of a cartridge 902 approachinginterference element 908 in accordance with an embodiment of the currentinvention. Optionally, leading face 919 of cartridge 902 includesprotruding sections 917 and indentations 918 a, 918 b and 918 c. Forexample, in FIG. 9A protrusions 917 include complementary interferenceelements that interlock with interference element 908. In the example ofFIG. 9A, leading face 919 is approaching interference element 908 out ofalignment. For example, complimentary interference elements 917 are notaligned to interlock with interference element 908 in the illustratedorientation of cartridge 902.

In some embodiments, the interference element 908 includes a pin. Forexample in the embodiment of FIGS. 9A-9C, the complimentary interferenceelements include a protrusion 917. Optionally a protruding interferenceelement may be part of the cartridge and/or the delivery device.Optionally an interference element of the delivery device may include anelastic part. Alternatively or additionally, an interference element onthe cartridge may include an elastic part. Optionally cartridge 902includes a connector 938. For example, connector 938 may include aseptum. For example, septum may connect to a needle 638 of the deliverydevice. Alternatively or additionally, a connector on a cartridge mayinclude a needle. For example, the needle may connect to a septum of adelivery device.

In some embodiments, a leading face of a cartridge reaches theinterference elements 908 of the delivery device out of alignment.Optionally, the driver realigns the cartridge 902 into alignment withinterference element 908. For example, when the cartridge 902 is fullyinserted, protrusion 917 overlaps and/or pushes interference element 908out of the way. For example, interference element 908 is displacedelastically. Pushing interference element 908 optionally adds aresistance to insertion of the cartridge. For example, displacement ofinterference element 908 may be by elastic flexing of element 908 (forexample as illustrated in FIG. 9B). Optionally, elastic displacement ofinterference element 908 allows cartridge 902 to be fully inserted untilit is fixed longitudinally in the cartridge bay.

In some embodiments, after insertion of the cartridge 902 into thecartridge bay, a driver is activated. Optionally, the driver reorientscartridge 902. For example, cartridge 902 is rotated as Illustrated byarrow 955 in FIG. 9B. Optionally rotation of the cartridge continuesuntil interference element 908 is overlaps with indentation 918 b. Oncethe interference element 908 is overlaps indentation 918 b, interferenceelement 908 optionally snaps into indentation 918 b. For example, bysnapping into the indentation 918b, interference element 908 locks theorientation of cartridge 902, for example as illustrated in FIG. 9C.Optionally, both edges of an indentation 918 b may be at a sharpincline. For example, both sides of an interference element may besharply angled, for example to lock in either direction. Alternativelyor additionally, one side of an indentation 918 b may be steeply angled(for example to prevent rotation in that direction) and/or another sidemay be at a shallow angle (for example to allow rotation in thatdirection). For example, rotation in a preferred direction requirebetween 100% to 50% the torque of rotation in an opposite directionand/or between 50% to 20% and/or between 20% to 5% and/or between 5% to1% and/or less that 1% as much force as rotating in the opposite(prevented) direction.

In some embodiments, when interference element 908 is interlocked withcomplimentary interference element 917, cartridge 902 is locked and itis orientation with respect to the delivery device, for example, asIllustrated in FIG. 9C. For example, when interference elements 908overlaps a protrusion 917, cartridge 902 may rotate until an indentation918 b overlaps with interference element 908 and/or interference element908 is in alignment for locking with complimentary interference 917. Forexample, when indentation 918 b overlaps with interference element 908,interference element 908 optionally snaps into indentation 918 b lockingthe orientation of cartridge 902. Alternatively or additionally, thecartridge 902 may be inserted with interference elements 908 and 917already in locking alignment. For example, interference element 908 mayimmediately slip into an indentation 918 a-918 c. When indentations 918a-918 c and 908 overlap and cartridge 902 it is fully inserted,interference element 908 may be unstressed. Alternately or additionally,interference element 908 may be displaced elastically when it isoverlaps with an indentation 918 a-918 c. For example, this may give atactile sign when the cartridge is fully inserted when the twointerference elements 908 and 917 are aligned to interlock.

Exemplary Interfaces Between a Driver and a Reservoir

FIG. 10 is a schematic illustration of a pharmaceutical cartridge inaccordance with an embodiment of the current invention. In someembodiments, a cartridge may include a driver. Optionally a drive mayinclude one part of the driver that is orientationally stabilized withrespect to the reservoir and/or a second part that is translationallystabilized with respect to the reservoir.

In some embodiments, a cartridge includes a driver. For example, adriver may include a TSA. For example, the TSA may include an internallythreaded element 1033, which is threadably connected to an externallythreaded pushing rod 1003. When element 1033 rotates with respect to rod1003 the rod is optionally translated with respect to element 1033.Optionally the element is connected to a reservoir NU of the cartridge,such that element 1033 does not translate linearly with respect toreservoir 1002 and/or does not separate from reservoir 1002. In someembodiments element 1033 can rotate with respect to reservoir 1002. Insome embodiments, rod 1003 is rotationally stabilized with respect toreservoir 1002. Alternatively or additionally, an internally threadedelement may be translationally stabilized and/or an externally threadedelement may be rotationally stabilized.

In some embodiments, element 1033 is connected to a transmission 1005.For example, transmission 1005 may connect to a motor, which optionallyrotates transmission 1005 and/or element 1033 with respect to a deliverydevice.

In some embodiments rod 1003 is rotationally stabilized with respect toa reservoir 1002. For example, the rod may be connected to a stabilizerpad 1093. Pad 1093 may cause friction between rod 1003 and an inner wallof reservoir 1002. For example when element 1033 is rotated with respectto a reservoir 1002, rod 1003 may rotate with element 1033 and/oralternatively rod 1003 make move linearly with respect to element 1033.Whether rod moves linearly or rotates is optionally controlled by thepitch of the screw threads connecting rod 1003 to element 1033 and/or bythe friction between pad 1093 and reservoir 1002.

In some embodiments, rod 1003 is connected to a plunger interface 1092.

Optionally, driving rod 1003 into reservoir 1002 couples plungerinterface 1092 to a plunger 1086 in the reservoir 1002. Further drivingrod 1003 into reservoir 1002, optionally drives plunger 1086 intoreservoir 1002 and/or discharges a pharmaceutical 1089. For example,pharmaceutical 1089 may be discharged out a distal end of reservoir 1002opposite element 1033. Alternatively or additionally, a cartridge maynot include a friction pad 1093. For example, plunger 1086 be connectedto rod 1003 and/or plunger 1086 may supply friction between the innerwall of reservoir 1002 and rod 1003.

The cartridge of the exemplary embodiment of FIG. 10 includes a hollowneedle 1036. For example when cartridge is inserted into a deliverydevice, needle 1036 may puncture a septum of the delivery device and/orsupply fluid path between reservoir 1002 and the delivery device. Acartridge optionally includes a proximal flange 1016.

In some embodiments, when reservoir 1002 is held stable with respect toa delivery device (for example by means of a cartridge stabilizationsystem) and/or transmission 1005 is rotated with respect to the deliverydevice, the pharmaceutical is discharged. Alternatively or additionally,when reservoir 1002 is not prevented from rotating with respect to thedelivery device, rotating transmission 1005 with respect to the deliverydevice may rotate reservoir 1002 with respect to the delivery deviceand/or may not cause discharge of the pharmaceutical 1089.

FIG. 11 is a schematic illustration of a pharmaceutical cartridge inaccordance with an embodiment of the current invention. In someembodiments, a cartridge may include a driver. Optionally a drive mayinclude one part of the driver that is orientationally stabilized withrespect to the reservoir and/or a second part that is translationallystabilized with respect to the reservoir.

In some embodiments, a cartridge includes a driver. For example, adriver may include a TSA. For example, the TSA may include a containingelement 1133, which is irrotationally connected to an externallythreaded pushing rod 1103 a. When element 1133 rotates, rod 1103 a isoptionally also rotated. Optionally element 1133 is connected to areservoir 1102 of the cartridge, such that element 1133 does nottranslate linearly with respect to reservoir 1102 and/or does notseparate from reservoir 1102. For example, a shoulder of element 1133may rest on a flange 1116 of reservoir 1102. In some embodiments element1133 can rotate with respect to reservoir 1102. In some embodiments, rod1103 a threadably connected to a second rod 1103 b. For example, rod1103 b includes an inner thread, which is coupled to the outer thread ofrod 1103 a. Additionally or alternatively, rod 1103 b includes an outthread that is coupled to an inner thread of a plunger interface 1192.

In some embodiments, element 1133 is connected to a transmission 1105.For example, transmission 1105 may connect to a motor, which optionallyrotates transmission 1105 and/or element 1133 with respect to a deliverydevice.

In some embodiments, plunger interface 1192 is connected to a plunger1186. Plunger 1186 is optionally in friction contact with an inner wallof reservoir 1102. For example when element 1133 is rotated with respectto a reservoir 1102, rod 1103 a may rotate with rod 1103 b and/oralternatively rod 1103 a rotate with respect to and/or move linearlywith respect to rod 1103 b. Alternatively or additionally, when rod 1103b is rotated with respect to a reservoir 1102, rod 1103 b may rotatewith plunger interface 1192 and/or alternatively rod 1103 b rotate withrespect to and/or move linearly with respect to plunger interface 1192.Whether parts moves linearly or rotate is optionally controlled by thepitch of the screw threads and/or by the friction between plunger 1186and reservoir 1102.

Optionally, driving interface 1192 into reservoir 1102, optionallydrives plunger 1186 into reservoir 1102 and/or discharges apharmaceutical 1189. For example, pharmaceutical 1189 may be dischargedout a distal end of reservoir 1102 opposite element 1133. For example,plunger 1186 be connected to interface 1192 and/or plunger 1186 maysupply friction between the inner wall of reservoir 1102 and interface1192 for example inhibiting rotation of interface 1192 with respect toreservoir 1102.

The cartridge of the exemplary embodiment of FIG. 11 includes a septum1138. For example when cartridge is inserted into a delivery device, aneedle of the delivery device may puncture a septum of the deliverydevice and/or supply fluid path between reservoir 1102 and the deliverydevice.

In some embodiments, when reservoir 1102 is held stable with respect toa delivery device (for example by means of a cartridge stabilizationsystem) and/or transmission 1105 is rotated with respect to the deliverydevice, the pharmaceutical is discharged. Alternatively or additionally,when reservoir 1102 is not prevented from rotating with respect to thedelivery device, rotating transmission 1105 with respect to the deliverydevice may rotate reservoir 1102 with respect to the delivery deviceand/or may not cause discharge of the pharmaceutical 1189.

FIG. 11 shows leading face 1119 of reservoir 1102 in accordance with anembodiment of the current invention. Optionally, leading face 1119 ofreservoir 1102 includes protruding sections 1117 and/or indentations1118. For example, a protrusion 1117 may include a complementaryinterference element that interlocks with an interference element of thedelivery device.

Exemplary Dimensions of a Drug Delivery Device

In some embodiments the payload of a reservoir (for example a syringe)may include, for example between 0.5 and 2 m; and/or between 2 and 5 mland/or between 5 and 7 ml and/or between 7 and 10 ml of a drug and/ormore. In some embodiments, the injector may discharge the entire payloadas a single dose. A drug delivery device may include, for example, apatch injector, and/or an internally powered driver to drive the plungerand/or discharge the payload.

For the sake of this application, an internally powered injector drivermay be defined as a drive mechanism powered by energy stored at leasttemporarily within the injector. Power may be stored in a power supply,for instance as chemical potential (for example a chemical that producesan expanding gas and/or a battery) and/or mechanical potential (forexample stored in an elastic member and/or a spring and/or a pressurizedgas). For example, the driver may be designed to discharge the payloadover a time period ranging between 20 and 120 seconds and/or between 120and 600 seconds and/or between 600 seconds and an hour and/or between anhour and a day and/or longer.

In some embodiments, the apparatus may be preprogrammed to wait a fixedtime delay ranging between 2 to 20 minutes and/or 20 minutes to an hourand/or an hour to 6 hours and/or 6 hours to 2 days after activationbefore beginning delivery of the substance. Optionally the length of thetime delay may be an estimated time for a temperature sensitivecomponent of the apparatus to reach a preferred working temperature. Forexample, the temperature sensitive component may include the drug and/ora battery.

In general, discharge may be driven by a driver. An internally powereddriver may be powered by various mechanisms including for example amotor as discussed, including for example a DC motor, an actuator, abrushless motor, and/or a transmission including for example atelescoping assembly and/or a threaded interference element and/or agear and/or a coupling and/or an elastic mechanism (for example a springand/or a rubber band) and/or an expanding gas and/or a hydraulicactuator).

A drug delivery device in accordance with some embodiments of thepresent invention may include a reservoir part as discussed. Forexample, a reservoir may include a medicine container and/or a syringe.Optionally a syringe may be preloaded with medicine using standardequipment and/or in an aseptic room. A preloaded syringe may optionallyinclude a proximal opening. A plunger may optionally seal the proximalopening and/or protect the sterility of the contents of the syringe. Asterile needle, typically hollow, may optionally be connected to thesyringe barrel. For example, the hollow of the needle may be in fluidcommunication with the interior of the barrel.

The needle may optionally be rigidly attached to the extension at thedistal end of the barrel. The sterility of all and/or part of the needlemay for example be protected by a protective cap. The protective cap mayremain on the needle when the syringe is supplied and/or installed intoan injector. For example, the medicine container may optionally includea cylindrical barrel rigidly attached to a needle. In some embodiments,a plunger may slide axially along the inside of the barrel to dischargea medicine payload. For example, the medicine may be discharged throughthe hollow needle. The protruding tip of the needle may be oriented atan angle to the axis of the barrel.

An aspect ratio of the base may be defined as the ratio of the length ofthe longest axis of the base to the shortest axis. Optionally the axisratio may range between 1 to 1.5 and/or 1.5 to 2 and/or between 2 to 3and/or greater than 3. In some embodiments, the height of the injectormay range between half the length of the short axis of the base to thelength of the short axis of the base and/or between the length of theshort axis of the base to twice the length of the short axis of the baseand/or greater than the twice length of the short axis of the base. Theheight of the injector may supply leverage for pivoting the adhesive offthe skin of a patient after use.

In some embodiments, the force to insert the needle to the skin of apatient may range for example between 0.02 to 0.2 N and/or between 0.2and 0.5 N and/or between .5 to 5 N. Optionally, the force required toinject the drug (for example the force on a syringe plunger) may rangefor example between 5 to 60 N. For example, the force required to injectthe drug may depend on the injection rate and/or the viscosity of thedrug and/or the syringe geometry and/or the needle dimensions.

In some embodiments, injection of medicine may be driven by a plunger.The plunger may optionally be driven by a threaded assembly, for examplea threaded screw and/or teeth and/or a telescoping assembly. Optionallythe pitch of the teeth and/or an associated screw may range for examplebetween 0.5 and 2 mm. The diameter of the screw may range for examplebetween 2.5 and 15 mm. The torque to power injection may range forexample between 0.2 and 1.0 N*cm. The trigger torque (the torque atwhich the needle safeguarding is triggered) may range for examplebetween to 0.5 to 2 and/or from 2 to 7 and/or from 7 to 10 N*cm.

During injection, the linear movement of a plunger may range for examplebetween 10-50 mm. The length of movement of the plunger may vary forexample with the volume of medicine to be injected that may range forexample between 0.5 to 3 ml.

In some embodiments a time of discharge may range may depend on the fillvolume and/or viscosity For example the expected injection speeds may beInjection speed depend on viscosity, for example for viscosity rangingfrom 1 cp to 15 cp the expected injection rage may range between 30 to70 sec/lml, for example for viscosity ranging from 15 cp to 60 cp theexpected injection rate may range between 35 to 60 sec/ml for viscosityabove 60 cp the expected injection rate may range between 53 to 67sec/lml. The maximum and/or minimum expected injection time may forexample be the maximum and/or minimum allowed fill volume divided by aninjection rate.

For example an expected time of discharge may range for example between24 to 78 seconds (for example for between 0.8 and 1.2 ml of fluid havinga viscosity ranging between 1 to 15 cp) and/or between 36 to 68 seconds(for example for between 1.2 and 1.7 ml of fluid having a viscosityranging between 1 to 15 cp) and/or between 51 to 92 seconds (for examplefor between 1.7 and 2.3 ml of fluid having a viscosity between 1 to 15cp) and/or between 70 to 150 seconds (for example for 2.0 to 2.5 ml offluid having a viscosity of between 15 and 70 cp) and/or between 120seconds and 3 minutes for larger volumes and/or viscosities. In someembodiments, injection times may be longer. The length of the injectiontime may be determined by considerations other than viscosity and/orvolume.

In some embodiments, the reservoir may have a length ranging for examplebetween 20 and 72 and/or 72 and 78 mm and/or 78 and 80 mm and/or 80 and200 mm. In some embodiments an internal cylindrical space of a reservoirmay have an average width ranging for example between 1 and 3 mm and/or3 and 10 and/or 10 and 15 mm and/or 15 and 25 mm and/or 25 and 50 mm.Optionally a reservoir may have a circular cross section such that widthis the diameter of the circle. In some embodiments, an extension mayhave a straight end portion with a length ranging for example between 1and 3mm or 3 and 7 mm or 7 and 8 or 8 and 10 mm or 10 and 15 mm or 15and 50 mm. In some embodiments, the exposed straight portion of a needlemay have a length ranging for example between 1 and 5 mm or 5 and 7 mmor 7 and 10 mm or 10 and 20 mm.

It is expected that during the life of a patent maturing from thisapplication many relevant technologies and/or materials will bedeveloped and the scope of the terms are intended to include all suchnew technologies and materials a priori.

As used herein the terms “about”, “approximately” and “substantially”refer to ±5%

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 7, from 1 to 5, from2 to 7, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 7, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseinterference elements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

1-20. (canceled)
 21. A system for loading pharmaceutical into apharmaceutical delivery device comprising: a cartridge including acylindrical reservoir having a longitudinal axis and containing thepharmaceutical; a cartridge bay in the pharmaceutical delivery device,said bay sized and shaped to receive said cartridge with saidcylindrical reservoir rotated in any of a first orientation and a secondorientation rotated around said longitudinal axis; a first interferenceelement on said cartridge and a second complementary interferenceelement on said delivery device, wherein said first interference elementon said cartridge and a second complementary interference element aredisengaged when said cartridge is fully received by said bay and saidreservoir is in any of said first orientation and said secondorientation; said first interference element and second complementaryinterface element interlocking when said cartridge is fully loaded intosaid bay and said cartridge is in a third orientation around saidlongitudinal axis, said interlocking preventing rotation of saidreservoir around said longitudinal axis in at least one direction,wherein the second complementary interference element is longitudinallydisplaced by said cartridge after the cartridge is inserted into thebay.
 22. The system of claim 21, wherein in said cartridge fits intosaid bay by longitudinal insertion.
 23. The system of claim 22, whereinsaid first interference element is located on a leading face of saidcartridge.
 24. The system of claim 21, wherein said complementaryinterference element contacts said cartridge only when the cartridge ismore than 97% inserted into said bay.
 25. The system of claim 21,wherein in said first orientation said first interference element andsaid second complementary interference element overlap in and at leastone element of said first interference element and said secondcomplementary interference element is configured for elasticallydisplacing to accommodate said overlap.
 26. The system of claim 25,wherein when said at least one element is configured to apply aresistance to insertion of said cartridge into said cartridge bay as aresult of said elastically displacing.
 27. The system of claim 26,further comprising a lock configured for counteracting said resistance.28. The system of claim 27, wherein said lock includes a latch.
 29. Thesystem of claim 21, wherein in said first orientation said firstinterference element and said second complementary interference elementare disengaged facilitating rotation either direction around saidlongitudinal axis with respect to said delivery device around.
 30. Thesystem of claim 29, wherein in said third orientation said interlockingof said first interference element and said second complementaryinterference element inhibits rotation of said cartridge around saidlongitudinal axis with respect to said delivery device in two oppositedirections.
 31. The system of claim 21, further comprising a driver forimparting a torque between said pharmaceutical delivery device and saidcartridge around said longitudinal axis.
 32. The system of claim 31,wherein said driver is configured to drive discharge of saidpharmaceutical when said cartridge is prevented from rotating aroundaxis in said at least one direction.
 33. The system of claim 32, whereinsaid driver includes a threaded element.
 34. The system of claim 33,wherein said drive pushes a plunger axially inside of said cylindricalreservoir.
 35. The system of claim 34, wherein said driver includes atelescoping screw assembly.
 36. The system of claim 34, wherein saiddriver applies said torque to said threaded element and said threadedelement is threadably connected to a second threaded element and saidsecond threaded element is inhibited from rotating around saidlongitudinal axis with respect to said cartridge.
 37. A method ofloading a pharmaceutical cartridge having a cylindrical reservoir into adelivery device comprising; inserting the cartridge longitudinally intoa cartridge bay of the delivery device in a first orientation; applyinga torque to the cartridge with a driver; reorienting the cartridge to asecond orientation around a longitudinal axis of said reservoir as aresult of said applying a torque; interlocking an interference elementon the cartridge to a complementary interference element on the deliverydevice to lock the cartridge in said second orientation, saidcomplementary interference element being displaced longitudinally bysaid cartridge after said cartridge is inserted into said bay;discharging a pharmaceutical from the cartridge as a result ofcontinuing said applying and said interlocking.
 38. The method of claim37, further comprising: elastically displacing an interference elementas a result of said inserting; at least partially releasing saidelastically displacing when the cartridge reaches said secondorientation.
 39. The method of claim 38, wherein said elasticallydisplacing produces a resistance to said inserting and furthercomprising: fixing the cartridge in the cartridge bay after saidelastically displacing and wherein said fixing at least partiallycounteracts said resistance.